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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0358-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "URINE COLLECTION KIT, SKU DYKM1848A  DYKM2005  DYKM2151  DYLAB1004  DYLAB1004A  DYLAB1006  DYLAB1012  ; Component No. 503581",
  "description": "FDA recall Z-0358-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling URINE COLLECTION KIT, SKU DYKM1848A  DYKM2005  DYKM2151  DYLAB1004  DYLAB1004A  DYLAB1006  DYLAB1012  ; Component No. 503581 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0358-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "URINE COLLECTION KIT, SKU DYKM1848A  DYKM2005  DYKM2151  DYLAB1004  DYLAB1004A  DYLAB1006  DYLAB1012  ; Component No. 503581",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0358-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0358-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling URINE COLLECTION KIT, SKU DYKM1848A  DYKM2005  DYKM2151  DYLAB1004  DYLAB1004A  DYLAB1006  DYLAB1012  ; Component No. 503581",
      "text": "The FDA logged enforcement record Z-0358-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling URINE COLLECTION KIT, SKU DYKM1848A  DYKM2005  DYKM2151  DYLAB1004  DYLAB1004A  DYLAB1006  DYLAB1012  ; Component No. 503581 — reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-23. Affected lots/codes: SKU DYKM1848A - UDI/DI: 40193489228145 (Case), 10193489228144 (Ea) - Lots: 19LAA062 19LAA679 19LAB089 20AAA248 20AAA946;  SKU DYKM2005 - UDI/DI: 40193489475549 (Case), 10193489475548 (Ea) - Lots: 21ABL580 21DBG554 21JBC048 21JBE414 21JBM540 21KBK233 21LBJ354 21LBJ398;  SKU DYKM2151 - UDI/DI: 40195327132126 (Case), 10195327132125 (Ea) - Lots: 24EMG654 24IMA511;  SKU DYLAB1004 - UDI-DI: 40193489438223 (Case), 10193489438222 (Ea) - Lots: 20KBQ534 21ABL545 21IBC805 21JBN917 21JBX167 21KBN889  SKU DYLAB1004A - UDI/DI: 40195327216680 (Case), 10195327216689 (Ea) - Lots: 22GMH357 22IMG479;  SKU DYLAB1006 - UDI/DI: 40193489863575 (Case), 10193489863574 (Ea) - Lots: 21DBP497 21ELA493 21FLA001 21FLA001Z 21GLA397 21GLA835 22DLA811 22DLA903 22ELA725 22ELA923 22GLB140 22HLA173 22HLA458 22HLB334 22KLA089 22KLA161 23ALA267 23ALA943 23ALA960 23BLA520 23DLA028 23DLA896 23ELA259 23ELA755 23GLA515 23HLA543 23KLA012 24ALA101 24ALA799 24BLA337 24DLA479 24ELA438 24FLA307 24GLA156 24HLA576 24HLA989 24ILA230;   SKU DYLAB1012 - UDI/DI: 40195327044122 (Case), 10195327044121 (Ea) - Lots: 21LBR785 22BBG465 22EBU527 22FBC688 22JBK244 22KBG840 22LBB361 23CBH872 23CBP152 23EBF399 23GBC712 23HBQ555 23IBT131 23KBK764 24ABG515 24CBH845 24CBP719 24DBJ359 24EBR584 24HBK276 24IBJ812. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "supported": true,
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0358-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0358-2025&lang=eng"
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      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0358-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0358-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0358-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0358-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0358-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0358-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-10-23",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "SKU DYKM1848A - UDI/DI: 40193489228145 (Case), 10193489228144 (Ea) - Lots: 19LAA062 19LAA679 19LAB089 20AAA248 20AAA946;  SKU DYKM2005 - UDI/DI: 40193489475549 (Case), 10193489475548 (Ea) - Lots: 21ABL580 21DBG554 21JBC048 21JBE414 21JBM540 21KBK233 21LBJ354 21LBJ398;  SKU DYKM2151 - UDI/DI: 40195327132126 (Case), 10195327132125 (Ea) - Lots: 24EMG654 24IMA511;  SKU DYLAB1004 - UDI-DI: 40193489438223 (Case), 10193489438222 (Ea) - Lots: 20KBQ534 21ABL545 21IBC805 21JBN917 21JBX167 21KBN889  SKU DYLAB1004A - UDI/DI: 40195327216680 (Case), 10195327216689 (Ea) - Lots: 22GMH357 22IMG479;  SKU DYLAB1006 - UDI/DI: 40193489863575 (Case), 10193489863574 (Ea) - Lots: 21DBP497 21ELA493 21FLA001 21FLA001Z 21GLA397 21GLA835 22DLA811 22DLA903 22ELA725 22ELA923 22GLB140 22HLA173 22HLA458 22HLB334 22KLA089 22KLA161 23ALA267 23ALA943 23ALA960 23BLA520 23DLA028 23DLA896 23ELA259 23ELA755 23GLA515 23HLA543 23KLA012 24ALA101 24ALA799 24BLA337 24DLA479 24ELA438 24FLA307 24GLA156 24HLA576 24HLA989 24ILA230;   SKU DYLAB1012 - UDI/DI: 40195327044122 (Case), 10195327044121 (Ea) - Lots: 21LBR785 22BBG465 22EBU527 22FBC688 22JBK244 22KBG840 22LBB361 23CBH872 23CBP152 23EBF399 23GBC712 23HBQ555 23IBT131 23KBK764 24ABG515 24CBH845 24CBP719 24DBJ359 24EBR584 24HBK276 24IBJ812",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.",
            "Status": "recorded"
          }
        }
      ]
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}